Radiofrequency ablation to eliminate varicose veins may cut down on initial pain and complications compared with laser treatment, researchers said.
In a randomized trial, pain and tenderness, skin discoloration from bleeding in the treated area, and quality of life significantly favored radiofrequency ablation in the first weeks after treatment, J. Andrew Williamson, M.D., of the Dotter Interventional Institute in Portland, and colleagues found.
However, the only significant difference at one month compared with endovenous laser therapy was a lower total adverse event rate among radiofrequency-treated patients (4.4% versus 22.0% of treated limbs, P=0.021), they reported here at the Society of Interventional Radiology meeting.
Even so, these early advantages may be enough to sway outpatients' choice of treatment, commented William T. Kuo, M.D., of Stanford University in Stanford, Calif.
"Whatever you can do to reduce their discomfort is much appreciated by patients," said Dr. Kuo, a moderator at the session where the findings were presented.
Whether a procedure that is gentler in the short term incurs a longer-term cost in vessel recanalization remains to be seen, he noted.
The researchers followed patients for only one month in the multicenter, prospective trial, which included 87 veins in 69 patients. The subjects were randomized to treatment of the great saphenous vein with the ClosureFAST radiofrequency catheter or endovenous laser.
Radiofrequency treatment applies heat targeted directly at the vessel wall to contract collagen and damage the endothelium with delayed inflammation and fibrosis that closes the vessel.
Laser ablation at the 980 nm range used in the study also works through thermal damage to the endothelium but targets hemoglobin with steam bubbles produced as blood is heated.
Patients remained blinded to the exact form of treatment with protective goggles for all procedures, and the apparatus was covered with a sheet. Treatment afterward was identical for both groups, with compression bandages for the first 24 to 72 hours and thigh-high compression stockings for two weeks.
Most patients in both groups had clinical class-two varicose veins without ankle edema, skin pigmentation, or ulcers. The women were primarily seeking symptom relief.
After their respective procedures, all patients in both groups had vein occlusion and elimination of blood reflux.
Total procedure time averaged a few minutes less with radiofrequency (12.6 minutes versus 16.0 (catheter-in to catheter-out, P<0.09). Dr. Williamson noted that this was expected because the newer radiofrequency catheter treats veins in segments rather than with slow withdrawal, like laser treatment.
By one month, all pain and other outcome measures were statistically similar between groups.
However, early results consistently favored radiofrequency ablation for varicose vein treatment. The findings included:
- Lower peak self-reported pain levels at two days (P=0.0002), seven days (P<0.0001), and 14 days (P<0.0001)
- Less tenderness at two days (P=0.0073), seven days (P=0.0004), and 14 days (P=0.0011)
- Less than half as many patients with clinician-reported ecchymosis in the treated area through 14 days (all P<0.0001).
Varicose vein severity dropped faster and quality of life related to pain and physical function improved more quickly for radiofrequency-treated patients than those in the laser ablation group. Once again, all outcome measures converged to statistical similarity between groups at one month.
The reason behind the short-term differences may be higher temperatures in the laser treatment, more vein wall perforation, and greater thrombotic reaction than with the radiofrequency technique, Dr. Williamson said.
These were problems the new generation of radiofrequency ablation device was designed to overcome, he noted.
He cautioned that further study is needed to determine long-term vessel patency in a larger patient population, and with a new generation of laser systems that became available after the study began. They use different wavelengths and modified catheter tips to address perforation and temperature issues.
The study was sponsored by VNUS Medical Technologies. Drs. Williamson and Kuo reported no conflicts of interest.